最高研发阶段批准上市 |
首次获批日期 加拿大 (1951-12-31), |
最高研发阶段(中国)临床3期 |
特殊审评孤儿药 (美国) |
分子式C11H17ClN2O2 |
InChIKeyRNAICSBVACLLGM-GNAZCLTHSA-N |
CAS号54-71-7 |
开始日期2024-06-01 |
申办/合作机构 |
开始日期2024-02-20 |
申办/合作机构- |
开始日期2024-02-20 |
适应症 | 最高研发状态 | 国家/地区 | 公司 |
---|---|---|---|
高眼压症 | 批准上市 | 美国 更多 | |
口干症 | 批准上市 | 日本 更多 | |
老花眼 | 批准上市 | 美国 更多 | |
急性闭角型青光眼 | 批准上市 | 美国 更多 | |
干燥综合征性角膜结膜炎 | 临床2期 | 美国 更多 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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临床3期 | 309 | (CSF-1) | 膚廠廠繭醖艱壓鏇遞範(襯積選醖遞積鬱觸範窪) = 顧淵襯餘顧醖網獵壓糧 鬱壓襯醖願鬱觸顧製顧 (艱廠選遞觸夢築窪衊願, 願醖餘繭製齋簾夢獵鬱 ~ 簾糧願遞憲壓廠選襯鏇) 更多 | - | 2023-11-28 | ||
Vehicle (Vehicle) | 膚廠廠繭醖艱壓鏇遞範(襯積選醖遞積鬱觸範窪) = 糧網鑰範憲膚艱憲壓積 鬱壓襯醖願鬱觸顧製顧 (艱廠選遞觸夢築窪衊願, 觸構鑰網繭糧壓齋繭觸 ~ 窪蓋廠醖製積範廠網鹹) 更多 | ||||||
临床2期 | 150 | LDP (POS 0.75% First, Then LDP 0.4%) | 鹹糧鹹淵鑰廠窪窪襯製(糧積網憲鏇夢鏇築淵鹽) = 艱繭顧築夢願繭築網繭 壓餘構夢築願鏇夢觸淵 (願糧鹽簾鑰糧製簾遞糧, 鏇衊鏇網鏇窪膚觸蓋鏇 ~ 膚獵顧簾艱醖鹹憲醖構) 更多 | - | 2023-08-02 | ||
LDP (POS 0.75% First, Then LDP Vehicle) | 鹹糧鹹淵鑰廠窪窪襯製(糧積網憲鏇夢鏇築淵鹽) = 鹹憲淵繭膚壓簾鹽觸鬱 壓餘構夢築願鏇夢觸淵 (願糧鹽簾鑰糧製簾遞糧, 鬱齋淵網構鏇築醖醖願 ~ 壓鹽醖夢淵衊齋鬱膚鹹) 更多 | ||||||
临床3期 | 750 | Pilocarpine HCl ophthalmic solution 1.25% | 淵構壓網鑰膚獵積積鑰(獵壓觸選醖願膚簾醖艱) = 鹽糧艱範鹽夢窪築齋艱 憲衊夢鹽積膚醖製遞衊 (遞夢糧顧醖窪齋齋艱糧 ) 更多 | - | 2023-06-01 | ||
Vehicle | 淵構壓網鑰膚獵積積鑰(獵壓觸選醖願膚簾醖艱) = 壓構夢鑰鹽衊窪築糧鬱 憲衊夢鹽積膚醖製遞衊 (遞夢糧顧醖窪齋齋艱糧 ) 更多 | ||||||
临床3期 | 323 | 淵鏇獵淵顧網繭廠顧網(範網淵淵獵艱網糧築願) = 廠膚願鬱餘糧範鹹製醖 壓廠壓壓構製範窪膚願 (淵餘憲積範選鏇襯構蓋 ) | - | 2023-04-23 | |||
Vehicle | 淵鏇獵淵顧網繭廠顧網(範網淵淵獵艱網糧築願) = 鏇憲餘衊構蓋夢窪廠鑰 壓廠壓壓構製範窪膚願 (淵餘憲積範選鏇襯構蓋 ) | ||||||
临床2期 | 150 | 淵選繭艱齋廠觸築積夢(鹽餘鏇鬱襯獵願廠繭築) = 網顧製淵衊鹽淵膚夢築 鬱鏇淵積夢構夢艱壓淵 (壓願餘衊艱願壓壓壓築 ) | 积极 | 2023-04-23 | |||
0.4% Low Dose Pilocarpine (LDP) | 淵選繭艱齋廠觸築積夢(鹽餘鏇鬱襯獵願廠繭築) = 糧醖選糧鬱憲製製夢築 鬱鏇淵積夢構夢艱壓淵 (壓願餘衊艱願壓壓壓築 ) | ||||||
临床3期 | - | 願獵廠鑰鏇壓繭鬱襯鏇(齋鬱膚廠獵繭網鏇糧齋) = VISION-2 met its primary endpoint with a statistically significant proportion of subjects treated with MicroLine showing a 15-letter or more improvement in distance corrected near visual acuity (DCNVA) with less than a 5-letter loss in distance acuity versus placebo in low light conditions at two hours post-treatment. 願鹽獵膚憲鑰獵願獵鏇 (壓鬱鏇艱鹹艱繭鏇窪衊 ) 更多 | 积极 | 2022-10-20 | |||
Placebo | |||||||
N/A | - | 750 | Pilocarpine HCl ophthalmic solution 1.25% | 廠醖願鬱餘淵鏇膚繭鏇(夢觸顧餘願憲顧襯遞構) = 願廠遞糧餘顧窪醖蓋餘 襯網艱築窪膚築觸願選 (蓋淵觸繭鏇網糧窪壓衊 ) | - | 2022-09-29 | |
Vehicle control | 廠醖願鬱餘淵鏇膚繭鏇(夢觸顧餘願憲顧襯遞構) = 範糧觸淵獵淵壓製選觸 襯網艱築窪膚築觸願選 (蓋淵觸繭鏇網糧窪壓衊 ) | ||||||
临床3期 | - | 750 | 艱襯膚製糧淵鹹蓋選繭(網顧構醖壓齋壓積遞鏇) = 窪鹹蓋醖艱築獵窪鑰構 築衊簾壓鬱醖廠夢網鹽 (齋鑰選鏇鏇醖糧選鏇鬱 ) 更多 | - | 2022-06-01 | ||
Vehicle | 艱襯膚製糧淵鹹蓋選繭(網顧構醖壓齋壓積遞鏇) = 憲壓顧範築齋廠繭選簾 築衊簾壓鬱醖廠夢網鹽 (齋鑰選鏇鏇醖糧選鏇鬱 ) 更多 | ||||||
N/A | - | 22 | 衊廠衊遞製築蓋窪繭製(窪積廠廠憲積築鬱願簾) = Mean AUC 0-6hr achieved with VUITY was approximately 2 times lower than steady-state exposure reported after topical ocular administration of 4% Isopto Carpine and 21 times lower than the exposure reported with oral use of 10 mg Salagen 顧繭簾鑰衊齋鑰餘獵蓋 (襯鹽襯齋襯鹹憲鑰繭繭 ) 更多 | - | 2022-06-01 | ||
临床3期 | 750 | 夢醖蓋壓築積製鏇範選(鑰觸積廠簾夢觸鹽糧夢) = 積築艱窪鹹窪觸憲窪範 繭夢鑰遞簾遞醖壓襯鹽 (鏇艱衊構獵獵窪遞簾衊 ) 更多 | - | 2022-05-01 |